Regulatory Science and Digital Capability Development Specialist

About this role

This role contributes to building and growing a learning ecosystem for the EU Medicines Regulatory Network (EMRN).

As a Regulatory Science and Digital Capability Development Specialist, you will be contributing to the development of the strategy of the EU Network Training Centre (EU NTC), its implementation and follow-up to deliver on EMA and the EMRN’s strategic goals.

Furthermore, you will lead on activities of the EU NTC and the EMA Digital Academy aimed at building capacity and capability across the EMRN, its partners and stakeholders as appropriate, in the areas of regulatory, scientific, data and digital topics relevant to public and animal health in Europe.

In this job you will

Perform duties reserved only for the Temporary Agent contractual category. 

• Coordinate and implement activities relating to capability and capacity building across the European Medicines Regulatory Network (EMRN) (and its partners and stakeholders as appropriate), in the areas of regulatory, scientific, data and digital topics relevant to public and animal health in Europe;
• Develop, define, execute and continuously adapt the EU Network Training Centre (EU NTC) strategy to meet evolving business and stakeholder needs;
• Identify and gather learning and development needs and priorities in liaison with the EU NTC Training Steering Group (TrSG) and Training Champions through different methods (e.g. surveys), identify gaps in learning, and ensure provision of suitable interventions and development of learning curricula in line with such needs ;
• Work with relevant subject matter experts externally and internally to develop training curricula and to design, the development and delivery of high-quality learning for EU Network staff, including advising on the use of learning technology / technology enabled solutions (training delivery mechanisms);
• In liaison with the EU NTC TrSG and Training Champions, plan and deliver a catalogue of training courses (face-to-face/virtual/e-learning) designed to meet the EU Network needs through the learning management system (LMS);
• Lead the implementation of policies, standards and quality guidelines for learning design, development and delivery, carrying out related research as needed;
• Coordinate the business support for the LMS, including data checks, consolidating query answers and FAQs, tracking implementation of agreed changes, designing processes and templates for monthly updates. This will include liaison and support with the Local Administrator network; 
• Set up and coordinate the reporting on the delivery of training to relevant fora, in particular to the TrSG; 
• Continuously improve the internal processes that support the EU NTC, particularly those requiring interaction with other areas of the EMA (IT, Talent Development); 
• Lead (in liaison with relevant EMA departments and offices) work / projects to extend (EU NTC) learning to (selected) external audiences including business case development, selection of best suited engagement platform and development of governance, processes and communication channels to include such audiences in the EU NTC learning service offering. Potential audiences include non-EU Regulators and Academia;
• Regularly provide updates on projects / initiatives to various stakeholders / general management when applicable.

Apply if you meet these eligibility criteria:

To be eligible for consideration for this position, you are required to meet the following general and specific eligibility conditions:
General conditions:
1. enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway;
2. have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language oft he European Union (at least level B2);
3. have fulfilled any obligations imposed by applicable laws concerning military service.
Specific conditions:
1. possess a university of a minimum of three years or more that must have been obtained by the closing date of this vacancy notice;
2. have at least 3 years of relevant professional experience after obtaining the relevant degree and before the closing date of this vacancy notice.

General Condition 1 and Specific Conditions 1 will be verified firstly based on the application form and then you will be required to provide documentary evidence at the interview stage. Failure to present these documents may result inthe disqualification from the selection procedure. Only eligible candidates will be assessed by the selection committee.

You will need

Experience

• At least 3 years of experience in developing training curricula/programmes/packages and/or designing, developing and delivering high-quality learning.

Skills & Knowledge

• Up-to-date knowledge of current trends and best practice in the postgraduate education sector and digital learning technologies
• Sound understanding of education development and quality assurance of educational programmes.
• Advanced IT capability with MS products, online development tools, accessibility requirements and an understanding of Learning Management Systems

Competencies you need to have:

Role competencies    

Understanding business context    Intermediate
Stakeholder relations management    Intermediate
Influencing and persuading    Intermediate

Sub-family competencies    

Scientific communication    Intermediate
Regulatory frameworks & strategy    Intermediate
Applied knowledge management    Intermediate

Grade competencies

Analysing and problem solving    Intermediate
Adaptability and agility    Intermediate
Prioritising and organising    Intermediate

Core competencies     
Ethics and integrity     Intermediate
Team collaboration    Intermediate
Customer centricity    Intermediate
Results orientation    Intermediate
Communication    Intermediate
Cross-cultural sensitivity    Intermediate
Continuous learning and self-development    Intermediate

For more information about definitions of competencies and associated proficiency levels, please refer to the EMA Competency Framework.
 

These are considered as Nice to have

Education

• A degree in Regulatory Science (health), Organisational Psychology, Education, Human Resource Development, Communication, Business Administration, other Social Sciences or Life Sciences.

Experience

• Experience in a competent authority in the field of medicines regulation, the pharmaceutical industry or in a healthcare / academic setting;
• Experience in coordinating teams and/or resources through an assigned task or project.
• Experience in the implementation of products using Agile and Lean methodologies.

Skills & Knowledge

• Knowledge of the EU regulatory framework for pharmaceuticals and EU health policies;
• Familiarity with a range of learning technologies tools and generative AI;
• Research skills